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Goal-based safety cases for medical devices : opportunities and challenges
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Sujan, Mark-Alexander, Koorrmeef, Floor and Voges, Udo (2007) Goal-based safety cases for medical devices : opportunities and challenges. In: Saglietti, F. and Oster, N., (eds.) Computer Safety, Reliability, and Security : Proceedings of 26th International Conference, SAFECOMP 2007, Nurmberg, Germany, September 18-21, 2007. Lecture Notes in Computer Science, Volume 4680 . Springer Verlag, pp. 14-27. ISBN 9783540751007
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Official URL: http://dx.doi.org/10.1007/978-3-540-75101-4_2
Abstract
In virtually all safety-critical industries the operators of systems have to demonstrate a systematic and thorough consideration of safety. This is increasingly being done by demonstrating that certain goals have been achieved, rather than by simply following prescriptive standards. Such goal-based safety cases could be a valuable tool for reasoning about safety in healthcare organisations, such as hospitals. System-wide safety cases are very complex, and a reasonable approach is to break down the safety argument into sub-system safety cases. In this paper we outline the development of a goal-based top-level argument for demonstrating the safety of a particular class of medical devices (medical beds). We review relevant standards both from healthcare and from other industries, and illustrate how these can inform the development of an appropriate safety argument. Finally, we discuss opportunities and challenges for the development and use of goal-based safety cases in healthcare.
| Item Type: | Book Item | ||||
|---|---|---|---|---|---|
| Subjects: | Q Science > QA Mathematics > QA76 Electronic computers. Computer science. Computer software | ||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Series Name: | Lecture Notes in Computer Science | ||||
| Journal or Publication Title: | Computer Safety, Reliability, and Security | ||||
| Publisher: | Springer Verlag | ||||
| ISBN: | 9783540751007 | ||||
| ISSN: | 0302-9743 | ||||
| Book Title: | Computer Safety, Reliability, and Security : Proceedings of 26th International Conference, SAFECOMP 2007, Nurmberg, Germany, September 18-21, 2007 | ||||
| Editor: | Saglietti, F. and Oster, N. | ||||
| Official Date: | 2007 | ||||
| Dates: |
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| Volume: | Volume 4680 | ||||
| Number of Pages: | 14 | ||||
| Page Range: | pp. 14-27 | ||||
| DOI: | 10.1007/978-3-540-75101-4_2 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access | ||||
| Conference Paper Type: | Paper | ||||
| Title of Event: | 26th International Conference on Computer Safety, Reliability and Security | ||||
| Type of Event: | Conference | ||||
| Location of Event: | Nuremberg, Germany | ||||
| Date(s) of Event: | 18-21 Sep 2007 | ||||
| Related URLs: |
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